OncoMatch/Clinical Trials/NCT06930794
A Study of Vebreltinib and Platinum-Containing Double Agents in Subjects With MET-Positive
Is NCT06930794 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Vebreltinib combined with platinum-based doublet chemotherapy. and platinum-based doublet chemotherapy. for non-small cell lung cancer.
Treatment: Vebreltinib combined with platinum-based doublet chemotherapy. · platinum-based doublet chemotherapy. — This study is an open-label, randomized, controlled, multicenter Phase IIIb clinical study, aiming to evaluate the efficacy, safety, and tolerability of Vebreltinib Enteric Capsule combined with platinum-based doublet chemotherapy compared with platinum-based doublet chemotherapy in treating subjects with locally advanced or metastatic non-squamous NSCLC who have not received previous systemic treatment and MET-positive. The target population of this study is subjects with histologically confirmed locally advanced or metastatic non-squamous NSCLC who have not received previous systemic anti-tumor treatment and MET-positive( MET Amplification or Overexpression). This study adopts an enrichment design. The enriched population is those with MET GCN ≥ 6, and the overall population is those with MET GCN ≥ 4. This study consists of two parts: the lead-in period (Part 1) and the randomized controlled period (Part 2). Both the lead-in period (Part 1) and the randomized controlled period (Part 2) will include a screening period (from Day -28 to Day -1), a treatment period (until the termination of treatment), and a follow-up period (including safety follow-up and survival follow-up).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: MET amplification (mean MET GCN ≥ 4 cells/cell or MET/CEP7 ≥ 2)
MET amplification is defined as the presence of MET amplification confirmed by second-generation sequencing (NGS) or fluorescence in situ hybridization (FISH) with a mean MET GCN ≥ 4 cells/cell or MET/CEP7 ≥ 2
Required: MET overexpression (c-Met showing strong positive (3+) staining in ≥50% of tumor cells by IHC)
MET overexpression is defined as c-Met showing strong positive (3+) staining in ≥50% of tumor cells as determined by immunohistochemistry (IHC) (central laboratory results)
Required: EGFR wild-type
tumor tissue specimen tested negative for sensitive epidermal growth factor receptor (EGFR) mutations (including exon 19 deletion, exon 21 L858R or L861Q mutations, exon 18 G719X mutations, exon 20 S768I/T790M mutations, or exon 20 insertion mutations)
Required: ALK wild-type
ALK fusion-negative
Required: ROS1 wild-type
ROS1 fusion-negative
Required: MET wild-type (exon 14 skipping mutation)
MET exon 14 skipping mutation-negative
Required: BRAF wild-type (V600E mutation)
BRAF V600E mutation-negative
Required: NTRK1 wild-type (fusion)
NTRK fusion-negative
Required: NTRK2 wild-type (fusion)
NTRK fusion-negative
Required: NTRK3 wild-type (fusion)
NTRK fusion-negative
Required: RET wild-type (fusion)
RET fusion-negative
Required: HER2 (ERBB2) wild-type (mutation)
ERBB2 (HER-2) mutation-negative
Required: KRAS wild-type (mutation)
KRAS mutation-negative
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 x 10^9/L; no platelet transfusions within 3 days, no RBC transfusions within 14 days, no hematopoietic growth factor therapy within 7 days (PEG-GCSF or EPO within 14 days)
Kidney function
creatinine clearance rate ≥50 mL/min (≥60 mL/min for those receiving cisplatin, Cockcroft-Gault formula)
Liver function
serum TBIL ≤ 1.5 x ULN (TBIL ≤ 3 x ULN and DBIL ≤ 1.5 x ULN in Gilbert's syndrome), serum ALT/AST ≤ 2.5 x ULN (≤ 5.0 x ULN for subjects with confirmed liver metastases)
Cardiac function
Mean QTcF > 470 ms (excluded), NYHA class II or higher (excluded), LVEF < LLN or <50% (excluded), significant arrhythmias, risk factors for QTc prolongation, recent MI/angina/CHF/cardiomyopathy/pulmonary embolism/CVA/TIA within 6 months (excluded)
good organ function as determined by medical evaluation (within 7 days prior to first study dose), including: Good hematologic status...Good hepatic function...Good renal function...Good coagulation function...cardiac exclusion criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify